Package and method for producing the same

Abstract

There is provided a package wherein a pharmaceutical composition containing a saccharide-degrading enzyme is contained in a container, whereby reduction in titer caused by a low amount of enzyme is suppressed. A package comprising a pharmaceutical composition and a container, wherein the pharmaceutical composition is a lyophilized preparation containing a saccharide-degrading enzyme as an active ingredient, and the container contains the pharmaceutical composition, the inner surface of the container comprising at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine resins.

The invention claimed is: 
     
       1. A package comprising
 a pharmaceutical composition and a container, 
 wherein the pharmaceutical composition is a lyophilized preparation containing a saccharide-degrading enzyme as an active ingredient, 
 wherein the container contains the pharmaceutical composition and has at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine resins at an inner surface of the container, 
 wherein the saccharide-degrading enzyme is chondroitinase ABC, and 
 wherein an amount of the enzyme in the container is less than 10 μg. 
 
     
     
       2. The package according to  claim 1 , wherein an enzyme activity per the container is less than 5 units. 
     
     
       3. The package according to  claim 1 , wherein the enzyme has a titer of not less than 0.3 unit/μg. 
     
     
       4. The package according to  claim 1 , wherein the package has a storage stability for a duration of not less than 12 months at 5° C.±3° C. 
     
     
       5. A method for producing a pharmaceutical composition contained in a container, the method comprising:
 putting a solution comprising a saccharide-degrading enzyme into the container having at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine resins on its inner surface, and 
 lyophilizing the solution, 
 wherein the saccharide-degrading enzyme is chondroitinase ABC, and 
 wherein an amount of the enzyme in the container is less than 10 μg. 
 
     
     
       6. The method according to  claim 5 , wherein a titer of the enzyme in the pharmaceutical composition is not less than 0.3 unit/μg. 
     
     
       7. The method according to  claim 5 , wherein an enzyme activity of the solution to be put into the container is less than 5 units. 
     
     
       8. A pharmaceutical composition obtained by lyophilizing a solution comprising a saccharide-degrading enzyme in a container which has at least one material selected from the group consisting of fine ceramics, silicone resins and fluorine resins at an inner surface of the container,
 wherein the saccharide-degrading enzyme is chondroitinase ABC, and 
 wherein an amount of the enzyme in the container is less than 10 μg. 
 
     
     
       9. The package according to  claim 1 , wherein an enzyme activity per the container is less than 5 units. 
     
     
       10. The package according to  claim 1 , wherein the enzyme has a titer of not less than 0.3 unit/μg. 
     
     
       11. The package according to  claim 2 , wherein the enzyme has a titer of not less than 0.3 unit/μg. 
     
     
       12. The package according to  claim 1 , wherein the package has a storage stability for a duration of not less than 12 months at 5° C.±3° C. 
     
     
       13. The package according to  claim 2 , wherein the package has a storage stability for a duration of not less than 12 months at 5° C.±3° C. 
     
     
       14. The package according to  claim 3 , wherein the package has a storage stability for a duration of not less than 12 months at 5° C.±3° C. 
     
     
       15. The method according to  claim 6 , wherein an enzyme activity of the solution to be put into the container is less than 5 units.